Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Chemistry ×
13,257 results
2041–2064 of 13,257
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 22, 2008
DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
K072523 · LBR
General Atomics
Chemistry · 137d
Cleared Jan 03, 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · JFY
Dade Behring, Inc.
Chemistry · 65d
Cleared Jan 03, 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395 · LBS
Diazyme Laboratories
Chemistry · 129d
Cleared Dec 27, 2007
CHOLESTRAK HDL CHOLESTEROL HOME TEST
K072836 · LBS
Accutech, LLC
Chemistry · 85d
Cleared Dec 21, 2007
PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4227, CLEVER CHEK...
K072784 · NBW
Taidoc Technology Corporation
Chemistry · 81d
Cleared Dec 21, 2007
IRISPEC,CA/CB/CC
K072640 · JJW
Iris Diagnostics
Chemistry · 94d
Cleared Dec 20, 2007
PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S)...
K072599 · NOE
Diadexus, Inc.
Chemistry · 97d
Cleared Dec 20, 2007
ENVOY 500 HDL
K071706 · LBS
Clinical Data, Inc.
Chemistry · 182d
Cleared Dec 18, 2007
ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE...
K071930 · LCX
Blue Cross Bio-Medical Co., Ltd.
Chemistry · 158d
Cleared Dec 14, 2007
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · MMI
bioMerieux, Inc.
Chemistry · 414d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717 · JIT
Dade Behring, Inc.
Chemistry · 78d
Cleared Dec 11, 2007
LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
K072835 · JJY
Bio-Rad, Diagnostics Grp.
Chemistry · 69d
Cleared Dec 11, 2007
LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
K072721 · DIF
Bio-Rad, Diagnostics Grp.
Chemistry · 76d
Cleared Dec 07, 2007
VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
K073157 · CEM
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · JJY
Biosite Incorporated
Chemistry · 58d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · JFM
Bayer Healthcare, LLC
Chemistry · 345d
Cleared Dec 06, 2007
FASTPACK HCG IMMUNOASSAY
K072264 · JHI
Qualigen, Inc.
Chemistry · 113d
Cleared Dec 04, 2007
MICROPROTEIN REAGENT SET
K070757 · JGP
Pointe Scientific, Inc.,
Chemistry · 259d
Cleared Dec 03, 2007
CREATININE (ENZYMATIC)
K070824 · JFY
Thermofisher Scientific OY
Chemistry · 252d
Cleared Dec 03, 2007
EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
K070053 · NBW
Eps Bio Technology Corp.
Chemistry · 333d
Cleared Nov 30, 2007
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200,...
K072783 · JKA
Smiths Medical Asd, Inc.
Chemistry · 60d
Cleared Nov 30, 2007
ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P...
K072115 · CGX
Horiba Abx
Chemistry · 121d
Cleared Nov 26, 2007
PRIMUS A1CARE ASSAY
K062658 · LCP
Primus Corp.
Chemistry · 446d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4...
K071224 · CDD
Dade Behring, Inc.
Chemistry · 195d